INTERSTIM® 3023 (UDI 00613994287731)Recalls & reported problems

Summary

The FDA's MAUDE database contains 110 adverse event reports that list this exact device (DI 00613994287731), received between Nov 10, 2016 and Mar 24, 2026 — classified as 66 injuries, 44 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (28 reports).

5 other recalls cover devices cleared under the same FDA submission (P970004); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 110 reports, in the reporter's own words as published by the FDA.

• InjuryMar 24, 2026Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY/BOWEL DYSFUNCTION IT WAS REPORTED THAT THEY HAVE A HISTORY OF A PREVIOUS INS "THAT CAME OUT". PATIENT REPORTED THE DEVICE WAS REJECTED AND THEY EXPERIENCED REDNESS, WARMTH, AND SWELLING AND THEY HAD TO HAVE EMERGENCY SURGERY TO REMOVE IT. PATIENT STATED THEY ENDED UP HAVING IT REMOVED.

  Patient problems: Burning Sensation; Erythema; Foreign Body Reaction; Swelling/ Edema

  MAUDE report 24676551 ↗
• MalfunctionApr 29, 2025Break; Difficult to Remove; Adverse Event Without Identified Device or Use Problem; Break; Difficult to Remove; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) REGARDING A PATIENT (PT) WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIM. IT WAS REPORTED THAT THE INS, EXTENSION AND PARTIAL LEAD WERE REMOVED ON (B)(6) 2020. HCP INQUIRING IF PT IS ELIGIBLE FOR MRI. HCP STATES, VIA IMAGING, THEY SEE 4 ELECTRODES, ONE RADIOPAQUE MARKER AND THEN A BRAIDED PORTION OF THE LEAD WITHOUT A RADIOPAQUE MARKER, PERHAPS IN TWO SEPARATE PIECES. HCP THEN READ FROM THE OPERATIVE NOTE STATING, "GENTLE ROCKED THE LEAD TO LIFT IT FROM THE FASCIA HOWEVER DURING THIS PROCESS THE LEAD FRACTURED AND ONLY THE FIRST 2 OR 4 TINES WERE REMOVED, THE REMAINING TINES WERE STILL IN S3. ANY EFFORTS TO EXTRACT WHAT REMAINS IS FUTILE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21928834 ↗
• InjuryJul 26, 2024Migration or Expulsion of Device; Migration or Expulsion of Device

  INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIM. IT WAS REPORTED THAT THE BATTERY WAS REPLACED BECAUSE IT HAD MOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19840835 ↗
• InjuryMar 29, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY/BOWEL DYSFUNCTION. IT WAS REPORTED THAT THEIR FIRST INS WAS REMOVED BECAUSE THE WIRES (LEADS) WERE ¿FAULTY¿. THE FIRST INS DEVICE ALSO NEVER COMPLETELY CONTROLLED SYMPTOMS.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19003785 ↗
• MalfunctionNov 15, 2023Premature Discharge of Battery; Energy Output Problem; Premature Discharge of Battery; Energy Output Problem

  INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIM. THE REASON FOR CALL WAS PATIENT REPORTED THEY ONLY USED THE DEVICE FOR ABOUT 2 MONTHS AND THEY HAD TO HAVE IT ON SO HIGH THAT IT MADE THEM EXTREMELY UNCOMFORTABLE. PT CLARIFIED THEY ONLY USED IT UNTIL PROBABLY (B)(6) 2010 AT THE LONGEST WHEN THIS OCCURRED. PT REPORTED THEY DON'T KNOW IF THEIR IMPLANT BATTERY IS STILL ACTIVE "BECAUSE IT'S BEEN 14 YEARS". REDIRECTED PT TO THEIR HEALTHCARE PROVIDER TO CHECK THEIR IMPLANT BATTERY STATUS. PT INQUIRED IF THEY CAN CONNECT WITH THEIR IMPLANT WITH THEIR 3037 PROGRAM IF THAT WILL TELL THEM THE IMPLANT IS STILL ACTIVE. AGENT REVIEWED GENERAL OVERVIEW OF CONNECTING WITH PATIENT'S IMPLANT AND HOW TO CHECK INS BATTERY STATUS. PT STATED THEY WILL FIGURE OUT HOW TO USE THEIR PROGRAMMER BECAUSE IT'S BEEN SO LONG SO THEY WILL SEE IF THE BATTERIES ARE STILL WORKING OR NOT.

  Patient problems: Device Overstimulation of Tissue; Discomfort

  MAUDE report 18145568 ↗
• InjuryOct 2, 2023Difficult to Remove; Difficult to Remove

  INFORMATION WAS RECEIVED FROM A FRIEND/FAMILY MEMBER REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR GASTROINTESTINAL/ PELVIC FLOOR AND URINARY DYSFUNCTION/SACRAL NERVE STIM. THE REASON FOR CALL WAS PATIENT REP REPORTED PT'S IMPLANT IS NO LONGER ACTIVE AS IT HAS BEEN REMOVED BUT REPORTED PT'S LEADS WERE LEFT IMPLANTED. PATIENT REP STATED PT HAS BEEN TURNED DOWN FOR MRI SCANS DUE TO THE LEADS LEFT IMPLANTED. PATIENT REP INQUIRED IF PT IS ALLOWED TO HAVE HEAD/NECK MRI SCAN WITH LEADS LEFT IMPLANTED. PT STATED THE MRI FACILITY TOLD PT THEY CAN'T HAVE THE MRI BUT STATED THE UROLOGIST TOLD PT THEY COULD. REVIEWED MRI COMPATIBILITY AND REDIRECTED PT TO THEIR HEALTHCARE PROVIDER TO FURTHER DISCUSS. AGENT INQUIRED WHY THE LEADS WERE LEFT IMPLANTED AND PT STATED THEY ASSUME IT'S BECAUSE HCP "RAN INTO A LOT OF SCAR TISSUE" BUT STATED THEY ARE NOT SURE. PATIENT REP STATED PT IS JUST ASSUMING THAT BUT THE DOCTOR DID NOT SPECIFY. PT STATED IN THE BACKGROUND THAT THEY WERE TOLD THEY COULD NOT BE REMOVED. WHEN AGENT ASKED FOR EVENT DATE PT STATED IN THE BACKGROUND THAT THE FIRST IMPLANT WAS PUT IN 2007 AND IN 2014 THE DEVICE WAS REMOVED AND A NEW IMPLANT WAS PU

  Patient problems: Device Embedded In Tissue or Plaque; Scar Tissue

  MAUDE report 17855630 ↗
• InjuryOct 24, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIM. IT WAS REPORTED THAT  PATIENT HAD 3 DIFFERENT ATTEMPTS TO HAVE THE SYSTEM EXPLANTED / REVISION SINCE 2010-2016.CALLER REPORTS X-RAY SHOWS THE LAST PORTION OF THE LEAD IMPLANTED, INS EXPLANTED. CALLER REPORTS THIS ATTEMPTS OF REMOVAL WAS DONE (B)(6) 2016.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15661135 ↗
• InjuryJun 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT (B)(6), WAS EXPERIENCING LOWER BACK PAIN, CRAMPING IN BLADDER AREA, AND FEELING HER BLADDER FILLING UP AND WENT TO THE EMERGENCY ROOM HOSPITAL (B)(6), PER THE DIRECTION OF HER DOCTOR WAS. PATIENT  HAS A FOLLOW UP VISIT TOMORROW, (B)(6) AND WILL BE GOING INTO SURGERY NEXT WEEK REGARDING A NEW IMPLANT.

  Patient problems: Cramp(s) /Muscle Spasm(s); Pain; Urinary Retention

  MAUDE report 14856575 ↗
• InjuryApr 13, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  ON 2022-APR-12 RP (HCP): INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIM AND GASTROINTESTINAL/ PELVIC FLOOR. IT WAS REPORTED THAT PATIENT HAD A PROCEDURE FOR THEIR INTERSTIM GENERATOR AND LEAD EXPLANT. THEY DID A REVISION AND REPLACEMENT OF THE INTERSTIM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14103880 ↗
• MalfunctionApr 8, 2022Energy Output Problem; Inappropriate/Inadequate Shock/Stimulation; Battery Problem; Energy Output Problem; Inappropriate/Inadequate Shock/Stimulation; Battery Problem

  INFORMATION WAS RECEIVED FROM A PATIENT (VIA HEALTHCARE PROVIDER) WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT THE PATIENT (PT) HAS HAD DEVICE TURNED OFF FOR THE PAST FEW YEARS BUT THIS MORNING EXPERIENCED PAIN FROM STIMULATION DOWN BUTTOCK AND INTO RECTAL AREA. THE PT REPORTED THAT THEY TRIED TO CONNECT TO INS TO ENSURE IT WAS STILL TURNED OFF AND SAW AN EOS MESSAGE. PATIENT SERVICES WALKED THE PT THROUGH SYNCING OR HITTING THE OFF BUTTON. PATIENT SERVICES ALSO REVIEWED THE EOS MESSAGE. THE ISSUE WAS NOT RESOLVED THROUGH TROUBLESHOOTING. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE. ON (B)(6) 2022, THE MANAGING HCP OFFICE CALLED AND  STATED THAT THE PT'S STIMULATOR WAS SHOCKING THEIR BODY AND GENITALS. THE CALLER STATED THAT THE PT WAS SEEING EOS AND THAT THEY WERE ON THE WAY TO THE FACILITY RIGHT NOW TO EVALUATE. THE CALLER SAID THE PT'S STIMULATOR HAS BEEN 'TURNED OFF FOR SOME TIME' PRIOR TO THIS SITUATION. TECHNICAL SERVICES SPECULATED ON WHAT MAY BE CAUSING THIS (EMI, ETC). THE CALLER WAS GOING TO CALL BACK IF ASSISTANCE WAS NEEDED. TECHNICAL SERVICES ADVISED STARTING BY JUST TRYING TO CONNECT WITH 88

  Patient problems: Electric Shock; Pain

  MAUDE report 14052614 ↗
• InjuryJan 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR INTERSTIM - OTHER. IT WAS REPORTED THAT THE PATIENT'S ENTIRE SYSTEM WAS REMOVED ABOUT A YEAR AFTER IT WAS IMPLANTED BECAUSE IT GAVE THEM A BUNCH OF PROBLEMS. IT MADE THEIR CONDITION WORSE.

  Patient problems: Insufficient Information

  MAUDE report 13333543 ↗
• InjuryDec 16, 2021Battery Problem; Insufficient Device Problem Information; Battery Problem; Insufficient Device Problem Information

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT. THEY REPORTED THAT THE DEVICE QUIT WORKING. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED AT THIS TIME.

  Patient problems: Pain; Urinary Retention

  MAUDE report 13020364 ↗
• MalfunctionDec 13, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIM. IT WAS REPORTED THAT THE PATIENT IS NEEDING MRI OF ABDOMEN, CALLER IS INQUIRING IF THE PATIENT IS ELIGIBLE. THE CALLER REPORTED THAT A NOTE FROM THE PATIENT'S HCP INDICATED THAT THE "BATTERY FAILED". THE CALLER WAS UNABLE TO CLARIFY FURTHER. THERE WERE NO  PATIENT COMPLICATIONS REPORTED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12982906 ↗
• MalfunctionOct 14, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIM. IT WAS REPORTED BY THE HEALTH CARE PROFESSIONAL (HCP) THAT THE PATIENT INDICATED THE INS HAD NOT BEEN WORKING FOR YEARS. THEY NOTED THAT IT WAS UNKNOWN FOR HOW MANY YEARS IT HADN'T WORKED. THE CALLER REPORTED THAT THE INS HAD BEEN OFF AND TECHNICAL SERVICES REVIEWED MRI GUIDELINES. ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT. THEY REPORTED THAT THEY HAD NOT CONTACTED THE DOCTOR WHO MANAGED THEIR DEVICE ABOUT THEIR INS NOT HAVING WORKED FOR YEARS. THERE WAS NOBODY IN THEIR CITY AT THEIR CLINIC. WHEN ASKED WHEN THEY FIRST NOTICED THE ISSUE, THEY STATED THEIR BATTERY WAS REPLACED IN 2008. IT WAS UNKNOWN IF THE INS NOT HAVING WORKED FOR YEARS WAS CAUSED BY NORMAL BATTERY DEPLETION. WHEN ASKED WHAT MOST LIKELY CAUSED OR CONTRIBUTED TO THE ISSUE, THEY RESPONDED, "COULD LEAD PLACEMENT OF MOVED OR WAS BATTERY PLACED CORRECT. NO ONE SEEMS TO BE ABLE TO ANSWER OR WORK ON DEVICE AT [THEIR CLINIC]."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12632525 ↗
• InjuryOct 7, 2021Migration or Expulsion of Device; Insufficient Device Problem Information; Migration or Expulsion of Device; Insufficient Device Problem Information

  ADDITIONAL INFORMATION RECEIVED FROM THE PATIENT STATED THEIR SYSTEM WAS NOT CONTROLLING SYMPTOM AND THE CAUSE WAS NOT DETERMINED FOR NOT PERFORMING AS THEY LIKE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12591628 ↗
• InjuryOct 6, 2021Malposition of Device; Insufficient Device Problem Information; Malposition of Device; Insufficient Device Problem Information

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT. THEY REPORTED THAT THEIR INS WAS CHANGED FROM THE RIGHT SIDE TO THE LEFT IN 2017 BECAUSE THEY "DIDN'T LIKE THE WAY IT BULGED OUT" BUT PATIENT DID NOT KNOW THE DATE THAT WAS NOTICED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12587042 ↗
• InjuryJul 12, 2021Difficult to Remove; Insufficient Device Problem Information; Difficult to Remove; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIM. IT WAS REPORTED THAT THE PATIENT'S INS WAS REMOVED, BUT THEY COULD NOT GET THE LEAD OUT BECAUSE THE LEAD WAS SO ATTACHED THEY DID NOT WANT TO DO ANY MORE WORK. THEIR DOCTOR RESOLVED THE DEVICE. ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT. THEY REPORTED THAT NO HEALTHCARE PROVIDER WAS CURRENTLY MANAGING THEIR DEVICE. THE INS WAS REMOVED AND THE LEAD WAS ATTEMPTED TO BE REMOVED IN (B)(6) OF 2021. THE CAUSE OF THE LEAD ABANDONMENT/NOT BEING ABLE TO GET THE LEAD OUT BECAUSE IT WAS SO ATTACHED (EXPLANT DIFFICULTY) WAS REPORTEDLY DETERMINED. WHEN ASKED WHAT MOST LIKELY CAUSED OR CONTRIBUTED TO THIS ISSUE, THEY RESPONDED "UNABLE TO DETACH LEADS." WHEN ASKED TO CLARIFY THE REPORT THEIR DOCTOR HAD RESOLVED THE DEVICE AND WHAT STEPS WERE TAKEN TO RESOLVE THE ISSUE, THEY REPLIED THE BATTERY WAS REMOVED AND THE LEADS WERE STILL ATTACHED. THE ISSUE WAS NOT YET RESOLVED. WHEN ASKED IF ADDITIONAL SURGERY WAS PLANNED TO REMOVE THE LEAD, THEY REPORTED THERE WAS NOT A PLANNED DATE YET.

  Patient problems: Device Embedded In Tissue or Plaque; Insufficient Information

  MAUDE report 12155209 ↗
• MalfunctionMay 20, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIM. IT WAS REPORTED THAT THE PATIENT HAS THE 4 CONTACT LEAD IMPLANTED AND IT IS NOT CONNECTED TO THE INS BASED ON AN XRAY IMAGE. THE CALLER INDICATED THAT THE PATIENT WAS NOT AWARE OF THE LEAD BEING IMPLANTED AND AN MD DETERMINED THIS BASED ON THE IMAGING. THE CALLER DID NOT HAVE ANY FURTHER INFORMATION ABOUT THE ISSUE. TROUBLESHOOTING WAS NOT REQUIRED. THE ISSUE WAS NOT RESOLVED THROUGH TROUBLESHOOTING.¿ NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11860389 ↗
• MalfunctionApr 6, 2021Energy Output Problem; Electromagnetic Compatibility Problem; Energy Output Problem; Electromagnetic Compatibility Problem

  INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR VOIDING DYSFUNCTION. IT WAS REPORTED THAT THE PATIENT WAS WALKING THROUGH A HALLWAY WHEN THE INS TURNED ON AND THE PATIENT STARTED FEELING STIM. PATIENT SAID IN THE HALLWAY THERE WAS A POSTING ABOUT AN ELECTRICAL ROOM BUT THE DOOR WAS CLOSED. PATIENT SAID 2-3 HOURS AFTER WALKING THROUGH THE HALLWAY THEY ARE STILL FEELING STIM. REVIEWED POSSIBILITY OF ENABLE REED SWITCH. PATIENT CONTACTED THE HCP THEY SAW FOR THE DEVICE AND THEY SAID SINCE THE PATIENT HASN'T BEEN THERE IN SO LONG THEY WERE NOT CONSIDERED A PATIENT.  PATIENT SAID THEY HADN'T USED THE DEVICE IN 5 YEARS AND DIDN'T KNOW WHERE THE PROGRAMMER WAS. REVIEWED INS COULD BE TURNED OFF BY PATIENT PROGRAMMER, CLINICIAN PROGRAMMER OR STRONG MAGNET.

  Patient problems: Insufficient Information

  MAUDE report 11618805 ↗
• MalfunctionJan 23, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) REGARDING A PATIENT WITH AN IMPLANTED NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIMULATION. A HEALTH CARE PROFESSIONAL (HCP) CALLING FOR MRI COMPATIBILITY REPORTED THAT THE PATIENT WAS REPORTING THAT THEIR DEVICE WAS NO LONGER FUNCTIONAL. TECHNICAL SERVICES REVIEWED MRI COMPATIBILITY. THERE WERE NO SYMPTOMS AND NO FURTHER COMPLICATIONS WERE REPORTED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11219971 ↗
• MalfunctionNov 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIM. IT WAS REPORTED THAT THE CALLER REPORTED THAT THE PATIENT HAD INS REMOVED IN (B)(6), BUT WERE UNABLE TO REMOVE THE LEAD PER PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10841638 ↗
• MalfunctionApr 8, 2020Energy Output Problem; Inappropriate/Inadequate Shock/Stimulation; Energy Output Problem; Inappropriate/Inadequate Shock/Stimulation

  ADDITIONAL INFORMATION RECEIVED FROM THE PATIENT. THE PATIENT STATED THE POWER WAS PUT TOO HIGH BY THE CLINICAL NURSE. THEY ADJUSTED THE POWER DOWN. SINCE THEN THE PATIENT DAUGHTER STATED THEIR MOTHER STARTED WITH BLEEDING IN THE URINE.

  Patient problems: Device Overstimulation of Tissue; Electric Shock

  MAUDE report 9935817 ↗
• MalfunctionFeb 20, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) REGARDING A PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIMULATION. CALLER SAID THE PATIENT SAID THEIR DEVICE WASN'T WORKING. AS A RESULT OF WHAT WAS REPORTED, THE HCP WAS WARM TRANSFERRED TO THE NATIONAL ANSWERING SERVICE TO PAGE A MANUFACTURE REPRESENTATIVE (REP). NO PATIENT SYMPTOMS WERE REPORTED AND NO FURTHER COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9732431 ↗
• MalfunctionFeb 12, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEURO STIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIM AND GASTROINTESTINAL/PELVIC FLOOR IT WAS REPORTED THAT THE DEVICE HAS NOT WORK FOR YEARS AND PATIENT JUST LEFT IT INSIDE HER SINCE SHE IS ALL RIGHT. NO SYMPTOMS REPORTED AND NO FURTHER COMPLICATIONS NOTED OR ANTICIPATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9701225 ↗
• MalfunctionJan 23, 2020Break; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Break; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT THE PATIENT HAD THE DEVICE BUT IT DID NOT WORK THAT GOOD. THE PROBLEM CAME WHEN THEY WANTED IT OUT. IT HAD GROWN TO THE NERVES AND THEY COULD NOT TAKE IT COMPLETELY OUT. NOW IT CAUSED PAIN IN THAT HIP AND DOWN THE LEG. THEY STATED WHEN IT GOES OFF IT WAS PAIN THAT STOPS THEM FROM WALKING. ADDITIONAL INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIM. IT WAS REPORTED THAT THE INS NEVER WORKED SO THEY HAD THE DEVICE REMOVED IN (B)(6) OR (B)(6) OF 2013. IT WAS STATED THAT A HEALTHCARE PROVIDER WAS REMOVING THEIR KIDNEY, BECAUSE OF BLADDER INFECTIONS, AND THE PATIENT TOLD THEM TO REMOVE THE IMPLANT AS WELL. IT WAS REPORTED THAT ¿IT BROKE OFF¿ AND WAS ATTACHED TO THE NERVE, AND THE HEALTHCARE PROVIDER COULD NOT GET THE REST OUT. IT WAS STATED THAT THE PATIENT PERIODICALLY GETS PAIN SO BAD THAT THEY HOLLER BECAUSE OF THE ABANDONED PORTION; IT IS ¿SO BAD, SHOOTING THROUGH THERE.¿ NO FURTHER PATIENT COMPLICATIONS ARE ANTICIPATED OR EXPECTED AS A RESULT OF THIS EVENT.

  Patient problems: Ambulation or Postural Difficulties; Complaint, Ill-Defined; Device Embedded In Tissue or Plaque; Pain; Therapeutic Effects, Unexpected

  MAUDE report 9622028 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P970004. One submission often covers many models, so check the product and lot details in each record.

• Z-0372-2025 · Sep 18, 2024 · Open, Classified
  Medtronic Recharger Kits, RS6230, RS7230, and RS5220A, containing components WR9230 and WR9220A Recharger for rechargeable implantable neurostimulators. The Rechargers are used wi
• Z-0998-2022 · Feb 28, 2022 · Terminated
  MEDTRONIC INTERSTIM THERAPY SYSTEM FOR URINARY CONTROL, which includes the following: a) Handset with Communicator, Model Numbers: 1) TH90Q01, 2) TH90QFA, 3) TH90PFA, 4) TH90GFA,
• Z-1147-2015 · Jan 9, 2015 · Terminated
  The Medtronic, Quadripolar ITREL 3 IPG, Model 7425, is a multiprogrammable device designed for use in the Stimulation of the Central Nervous System, Peripheral Nervous System, or m
• Z-0040-2008 · Jun 25, 2007 · Terminated
  Medtronic InterStim INS (Model 3023) with N'Vision Inter Stim-B software supplied on the Model 8870 Version MMB_01/NNB_01 with N'Vision Clinician Programmer Model 8840 or InterStim
• Z-0037-2008 · Jun 25, 2007 · Terminated
  Medtronic InterStim II INS Model 3058 with N'Vision InterStim-B Software supplied on the Model 8870 Version MMB_01/NNB_01 N'Vision with a Clinic an Programmer Model 8840. Implanta